K120776 is an FDA 510(k) clearance for the ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION. This device is classified as a Abutment, Implant, Dental, Endosseous (Class II - Special Controls, product code NHA).
Submitted by Biomet 3i (Palm Beach Gardens, US). The FDA issued a Cleared decision on September 11, 2012, 181 days after receiving the submission on March 14, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3630. To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation..
| 510(k) Number | K120776 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2012 |
| Decision Date | September 11, 2012 |
| Days to Decision | 181 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NHA - Abutment, Implant, Dental, Endosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3630 |
| Definition | To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation. |